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MANNKIND CORP

For the period ended Sep 30, 2025. Filed Nov 5, 2025.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2025 · Filed Nov 5, 2025

MNKD$3.90+3.7%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-06-30; filed 2025-08-06.

0000950170-25-103535

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2025-09-30; filed 2025-11-05.

0001193125-25-265813

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 69 previous paragraphs and 79 current paragraphs.

28 unchanged; 36 reworded; 11 added; 3 removed; 2 previous and 4 current paragraphs rearranged.

Tables are not compared: 9 previous and 9 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (11)

Current report

In October 2025, we acquired scPharmaceuticals Inc. ("scPharma") whose approved product, Furoscix, consists of a novel formulation of furosemide delivered via scPharma’s device supplier-developed on-body infusor, which delivers an 80 mg/10 mL dose over five hours. Furoscix was approved by the FDA for the treatment of congestion due to fluid overload in adults with New York Heart Association (“NYHA”) Class II/III and IV chronic heart failure. The commercial launch of Furoscix for congestion in patients with chronic heart failure commenced in the first quarter of 2023. In March 2025, Furoscix was also approved by the FDA for the treatment of edema due to fluid overload in adult patients with chronic kidney disease ("CKD") and launched in April 2025.

Current report

Gain on bargain purchase of $5.3 million for the three and nine months ended September 30, 2024 was the result of the excess of net assets acquired over consideration paid in the Pulmatrix Transaction.

Current report

Represents transaction fees incurred during the three and nine months ended September 30, 2025 associated with the acquisition of scPharma.

Current report

As of September 30, 2025, we had $66.0 million in insulin purchase commitments and $111.3 million principal amount of outstanding debt, consisting of:

Current report

$75.0 million aggregate principal amount under the Blackstone Credit Facility. The Blackstone Credit Facility will mature on August 6, 2030. As of September 30, 2025, the term loans thereunder bore interest at a rate per annum equal to 9.00%. The interest rate is subject to fluctuation. We have the option to prepay the loans under the Blackstone Credit Facility in whole or in part, subject to early prepayment fees on or prior to the third anniversary of the Closing Date. See Note 8 –Borrowingsfor further information related to the Blackstone Credit Facility.

Current report

In addition, in October 2025, we borrowed an additional $250.0 million in delayed draw term loans under the Blackstone Credit Facility to fund the acquisition of scPharma and the scPharma Debt Extinguishment (see Note 16 –Subsequent Events). Following this delayed draw, the SOFR Loans borrowed under the Blackstone Credit Facility will be subject to the Adjusted Term SOFR plus margin of 5.00% after the delivery of year-end financial statements.

Current report

To date, we have been able to timely make our required interest payments, but we cannot guarantee that we will be able to do so in the future. If we fail to repay, repurchase or redeem, as applicable, our outstanding indebtedness and/or notes when required, we will be in default under the applicable instrument for such indebtedness and may also suffer an event of default under the terms of other borrowing arrangements that we may enter into from time to time. Any of these events could have a material adverse effect on our business, results of operations and financial condition, up to and including the noteholders initiating bankruptcy proceedings or causing us to cease operations altogether.

Current report

In October 2025, we entered into the CVR Agreement with the rights agent party thereto, which governs the terms of the CVRs issued to the former stockholders of scPharma in the acquisition transaction. The maximum aggregate amount payable with respect to the CVRs issued at the closing of the acquisition is $59.7 million, subject to the achievement of certain regulatory and net sales milestones on or prior to the applicable milestone outside dates in accordance with the CVR Agreement.
Removed paragraphs (3)

Previous report

We are a biopharmaceutical company focused on the development and commercialization of innovative therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. Our signature technologies—Technosphere dry-powder formulations and Dreamboat inhalation devices—offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation.

Previous report

In August 2025, we entered into the Backstone Credit Facility, pursuant to which we made an additional borrowing of $75.0 million. See Note 16 -Subsequent Events for additional information.
Reworded paragraphs (36)

Previous wording

In our endocrine business unit, we currently commercialize two products: Afrezza (insulin human) Inhalation Powder, an ultra rapid-acting inhaled insulin indicated to improve glycemic control in adults with diabetes, and the V-Go wearable insulin delivery device, which provides continuous subcutaneous infusion of insulin in adults that require insulin. Afrezza was developed by us and received approval from the FDA in June 2014. Afrezza consists of a dry powder formulation of human insulin delivered from a small portable inhaler. V-Go received 510(k) clearance by the FDA in 2010 and has been available commercially since 2012. In May 2022, we acquired V-Go from Zealand Pharma A/S and Zealand Pharma US, Inc. V-Go is a mechanical basal-bolus insulin delivery system that is worn like a patch and can eliminate the need for taking multiple daily injections.

Current wording

We are a biopharmaceutical company focused on the development and commercialization of patient-centric therapies that address serious unmet medical needs for those living with cardiometabolic and orphan lung diseases. We currently commercialize two products: Afrezza (insulin human) Inhalation Powder, an ultra rapid-acting inhaled insulin indicated to improve glycemic control in adults with diabetes, and the V-Go wearable insulin delivery device, which provides continuous subcutaneous infusion of insulin in adults that require insulin. Afrezza was developed by us and received approval from the FDA in June 2014. Afrezza consists of a dry powder formulation of human insulin delivered from a small portable inhaler. V-Go received 510(k) clearance by the FDA in 2010 and has been available commercially since 2012. In May 2022, we acquired V-Go from Zealand Pharma A/S and Zealand Pharma US, Inc. V-Go is a mechanical basal-bolus insulin delivery system that is worn like a patch and can eliminate the need for taking multiple daily injections. The first product to come out of our orphan lung disease pipeline, Tyvaso DPI (treprostinil) inhalation powder, received FDA approval in May 2022 for the treatment of PAH and PH-ILD. Our development and marketing partner, United Therapeutics, began commercializing Tyvaso DPI in June 2022 and is obligated to pay us a royalty on net sales of the product. We also receive a margin on supplies of Tyvaso DPI that we manufacture for UT.

Previous wording

Our pipeline of potential treatments for orphan lung diseases includes inhaled clofazimine (MNKD-101) for the treatment of severe chronic and recurrent pulmonary infections, including nontuberculous mycobacterial ("NTM") lung disease. The FDA has designated inhaled clofazimine as both an orphan drug and as a qualified infectious disease product for the treatment of pulmonary NTM infections. It has also granted Fast Track designation to our development program. In 2024, we initiated a global Phase 3 registrational study of inhaled clofazimine with sites in the United States, Japan, South Korea, Taiwan, and Australia. We expect enrollment of subjects into this study to continue into 2026. The other major program in our pipeline is a dry-powder formulation of nintedanib (MNKD-201) for the treatment of idiopathic pulmonary fibrosis ("IPF"). In 2024, we conducted a Phase 1 clinical study of MNKD-201, which met its primary objective of demonstrating positive safety results and good tolerability in healthy volunteers. We are currently planning a global Phase 2 trial and we expect clinical trial site activation by year end 2025.

Current wording

Our pipeline of potential treatments for orphan lung diseases includes inhaled clofazimine (MNKD-101) for the treatment of severe chronic and recurrent pulmonary infections, including nontuberculous mycobacterial ("NTM") lung disease. The FDA has designated inhaled clofazimine as both an orphan drug and as a qualified infectious disease product for the treatment of pulmonary NTM infections. It has also granted Fast Track designation to our development program. In 2024, we initiated a global Phase 3 registrational study of inhaled clofazimine with sites in the United States, Japan, South Korea, Taiwan, and Australia. We expect enrollment of subjects into this study to continue into 2026. The other major program in our pipeline is a dry-powder formulation of nintedanib (MNKD-201) for the treatment of idiopathic pulmonary fibrosis ("IPF"). In 2024, we conducted a Phase 1 clinical study of MNKD-201, which met its primary objective of demonstrating positive safety results and good tolerability in healthy volunteers. We are currently initiating a global Phase 2 trial that is expected to begin enrolling patients in early 2026.

Previous wording

As of June 30, 2025, we had cash, cash equivalents and investments of $201.2 million, an accumulated deficit of $3.2 billion and a total stockholders’ deficit of $55.0 million. We had net income of $0.7 million and $13.8 million for the three and six months ended June 30, 2025, respectively. To date, we have funded our operations primarily through the sale of our equity and convertible debt securities, from the receipt of upfront and milestone payments from collaborations, from borrowings, from sales of Afrezza and V-Go, from royalties and manufacturing revenue from UT, from proceeds of the sale-leaseback of our manufacturing facility in Danbury, CT and from the sale of a portion of future royalties that we receive from UT.

Current wording

As of September 30, 2025, we had cash, cash equivalents and investments of $286.3 million, an accumulated deficit of $3.2 billion and a total stockholders’ deficit of $44.6 million. We had net income of $8.0 million and $21.8 million for the three and nine months ended September 30, 2025, respectively. To date, we have funded our operations primarily through the sale of our equity and convertible debt securities, from the receipt of upfront and milestone payments from collaborations, from borrowings, from sales of

Previous wording

The following table provides a comparison of the revenue categories for the three and six months ended June 30, 2025 and 2024 (dollars in thousands):

Current wording

The following table provides a comparison of the revenue categories for the three and nine months ended September 30, 2025 and 2024 (dollars in thousands):

Previous wording

Afrezza— Gross revenue from sales of Afrezza increased by $1.1 million, or 4%, for the three months ended June 30, 2025 compared to the same period in the prior year, primarily driven by increased price and higher demand. The gross-to-net adjustment was 32% of gross revenue, or $8.8 million, for the three months ended June 30, 2025 compared to 37% of gross revenue, or $9.8 million, for the same period in the prior year. The decreased gross-to-net percentage was primarily attributable to a decrease in rebates. As a result, net revenue from sales of Afrezza increased by $2.0 million, or 13%, for the three months ended June 30, 2025 compared to the same period in the prior year.

Current wording

Afrezza— Gross revenue from sales of Afrezza increased by $3.0 million, or 13%, for the three months ended September 30, 2025 compared to the same period in the prior year, primarily driven by increased price and higher demand. The gross-to-net adjustment was 30% of gross revenue, or $7.8 million, for the three months ended September 30, 2025 compared to 36% of gross revenue, or $8.3 million, for the same period in the prior year. The decreased gross-to-net percentage was primarily attributable to a decrease in rebates. As a result, net revenue from sales of Afrezza increased by $3.5 million, or 23%, for the three months ended September 30, 2025 compared to the same period in the prior year.

Previous wording

Gross revenue from sales of Afrezza increased by $3.4 million, or 7%, for the six months ended June 30, 2025 compared to the same period in the prior year, primarily driven by increased price and higher volume. The gross-to-net adjustment remained consistent at 34% of gross revenue, or $17.1 million, for the six months ended June 30, 2025 compared to $16.1 million, for the same period in the prior year. As a result, net revenue from sales of Afrezza increased by $2.5 million, or 8%, for the six months ended June 30, 2025 compared to the same period in the prior year.

Current wording

Gross revenue from sales of Afrezza increased by $6.4 million, or 9%, for the nine months ended September 30, 2025 compared to the same period in the prior year, primarily driven by increased price and higher demand. The gross-to-net adjustment was 32% of gross revenue, or $24.8 million, for the nine months ended September 30, 2025 compared to 35% of gross revenue, or $24.4 million, for the same period in the prior year. The decreased gross-to-net percentage was primarily attributable to a decrease in rebates. As a result, net revenue from sales of Afrezza increased by $5.9 million, or 13%, for the nine months ended September 30, 2025 compared to the same period in the prior year.

Previous wording

V-Go — Gross revenue from sales of V-Go decreased by $2.9 million, or 30%, for the three months ended June 30, 2025 compared to the same period in the prior year and was a result of lower demand partially offset by increased price. The gross-to-net adjustment was 39% of gross revenue, or $2.6 million, for the three months ended June 30, 2025 compared to 53% of gross revenue, or $5.1 million, for the same period in the prior year. The improved gross-to-net percentage was primarily attributable to a decrease in rebates related to implementation of a strategy to reduce active contracts. As a result, net revenue from sales of V-Go decreased by $0.4 million, or 8%, for the three months ended June 30, 2025 compared to the same period in the prior year.

Current wording

V-Go — Gross revenue from sales of V-Go decreased by $2.8 million, or 31%, for the three months ended September 30, 2025 compared to the same period in the prior year as a result of lower demand partially offset by increased price. The gross-to-net adjustment was 38% of gross revenue, or $2.3 million, for the three months ended September 30, 2025 compared to 47% of gross revenue, or $4.2 million, for the same period in the prior year. The improved gross-to-net percentage was primarily attributable to a decrease in rebates related to implementation of a strategy to reduce active contracts. As a result, net revenue from sales of V-Go decreased by $0.9 million, or 19%, for the three months ended September 30, 2025 compared to the same period in the prior year.

Previous wording

Gross revenue from sales of V-Go decreased by $5.7 million, or 30%, for the six months ended June 30, 2025 compared to the same period in the prior year and was primarily a result of lower demand partially offset by increased price. The gross-to-net adjustment was 38% of gross revenue, or $5.0 million, for the six months ended June 30, 2025 compared to 53% of gross revenue, or $10.1 million, for the same period in the prior year. The improved gross-to-net percentage was primarily attributable to a decrease in rebates related to a reduction in active contracts. As a result, net revenue from sales of V-Go decreased by $0.6 million, or 7%, for the six months ended June 30, 2025 compared to the same period in the prior year.

Current wording

Gross revenue from sales of V-Go decreased by $8.5 million, or 30%, for the nine months ended September 30, 2025 compared to the same period in the prior year and was primarily a result of lower demand partially offset by increased price. The gross-to-net adjustment was 38% of gross revenue, or $7.3 million, for the nine months ended September 30, 2025 compared to 51% of gross revenue, or $14.3 million, for the same period in the prior year. The improved gross-to-net percentage was primarily attributable to a decrease in rebates related to a reduction in active contracts. As a result, net revenue from sales of V-Go decreased by $1.5 million, or 11%, for the nine months ended September 30, 2025 compared to the same period in the prior year.

Previous wording

Collaborations and Services — Net revenue from collaborations and services decreased by $3.2 million, or 12%, for the three months ended June 30, 2025 compared to the same period in the prior year. The decrease in revenue was primarily attributable to decreased collaboration and service revenue from UT of $3.8 million driven by a decrease in revenue from product sold to UT of $2.7 million and a decrease in the recognition of deferred revenue of $1.0 million due to the net impact of one-time items. Royalty revenue from UT increased by $5.6 million, or 22%, for three months ended June 30, 2025 and $13.0 million, or 27%, for the six months ended June 30, 2025 due to UT's increase in net revenue from sales of Tyvaso DPI.

Current wording

Collaborations and Services — Net revenue from collaborations and services increased by $3.2 million, or 14%, for the three months ended September 30, 2025 compared to the same period in the prior year due to increases in revenue from our agreements with UT and Amphastar. The $2.7 million increase in revenue from UT was primarily attributable to an increase in revenue from product sold to UT of $3.4 million partially offset by decreases of $0.3 million in revenue from other agreements and $0.4 million related to the recognition of deferred revenue. The Amphastar co-promote agreement provided additional revenue of $0.5 million.

Previous wording

Net revenue from collaborations and services increased by $1.4 million, or 3%, for the six months ended June 30, 2025 compared to the same period in the prior year. The increase in revenue was primarily attributable to an increase in revenue from the Amphastar co-promote agreement of $1.0 million and an increase in UT CSA revenue. The increase in UT CSA revenue was primarily due to increased product sold to UT, and was partially offset by a decrease in other contractual reimbursements of $2.9 million.

Current wording

Net revenue from collaborations and services increased by $4.6 million, or 6%, for the nine months ended September 30, 2025 compared to the same period in the prior year due to increases in revenue from our agreements with UT and Amphastar. The $3.3 million increase in revenue from UT was primarily attributable to an increase in revenue from product sold to UT of $4.3 million partially offset by decreases of $0.6 million in revenue from other agreements and $0.4 million related to the recognition of deferred revenue. The Amphastar co-promote agreement provided additional revenue of $1.5 million.

Previous wording

The following table provides a comparison of the commercial product gross profit categories for the three and six months ended June 30, 2025 and 2024 (dollars in thousands):

Current wording

The following table provides a comparison of the commercial product gross profit categories for the three and nine months ended September 30, 2025 and 2024 (dollars in thousands):

Previous wording

Commercial product gross profit increased by $2.7 million, or 18%, for the three months ended June 30, 2025 compared to the same period in the prior year, primarily due to an increase in revenue for Afrezza and a decrease in cost of goods sold of Afrezza driven by decreased costs associated with increased efficiencies in manufacturing activities in our Danbury, CT facility, partially offset by the quarterly capacity fee through our agreement with Amphastar.

Current wording

Commercial product gross profit increased by $1.3 million, or 8%, for the three months ended September 30, 2025 compared to the same period in the prior year primarily due to an increase in revenue for Afrezza partially offset by an increase in cost of goods sold. Afrezza cost of goods sold increased primarily due to the quarterly capacity fee of $0.4 million associated with our Amphastar agreement which began in the first quarter of 2025. This increase was partially offset by increased efficiencies in manufacturing activities in our Danbury, CT facility.

Previous wording

Commercial product gross profit increased by $2.9 million, or 10%, for the six months ended June 30, 2025 compared to the same period in the prior year, primarily due to an increase in revenue for Afrezza and lower cost of goods sold for V-Go, which was driven by lower production and sales volumes.

Current wording

Commercial product gross profit increased by $4.2 million, or 9%, for the nine months ended September 30, 2025 compared to the same period in the prior year primarily due to an increase in revenue for Afrezza partially offset by a decrease in revenue for V-Go.

Previous wording

The following table provides a comparison of the expense categories for the three and six months ended June 30, 2025 and 2024 (dollars in thousands):

Current wording

The following table provides a comparison of the expense categories for the three and nine months ended September 30, 2025 and 2024 (dollars in thousands):

Previous wording

Cost of revenue – collaborations and services remained consistent for the six months ended June 30, 2025 compared to the same period in the prior year. The increase in costs of sales associated with an increase in the number of blisters sold was offset by a decrease in cost per blister due to increased efficiencies in manufacturing activities in our Danbury, CT facility.

Current wording

Cost of revenue – collaborations and services increased by $0.9 million, or 6%, for the three months ended September 30, 2025 and $1.0 million, or 2%, for the nine months ended September 30, 2025 compared to the same periods in the prior year. The increases were primarily attributable to an increase in production related inventory write-offs for the period in addition to increase in costs of sales associated with an increase in the number of blisters sold, which was partially offset by decreases in cost per blister due to increased efficiencies in manufacturing activities in our Danbury, CT facility.

Previous wording

Research and development expenses increased by $1.9 million, or 16%, for the three months ended June 30, 2025 compared to the same period in the prior year. The increase was primarily attributable to continued patient enrollment in our ICoN-1 clinical study for MNKD-101, clinical production scale-up for MNKD-201, and personnel costs primarily due to additional headcount as a result of the Pulmatrix transaction in the third quarter of 2024, which bolstered our research capabilities and capacity. These increases were partially offset by the completion of our Afrezza post-marketing clinical study (INHALE-3) and Phase 1 MNKD-201 studies in 2024, as well as lower costs for our Afrezza Pediatric clinical study (INHALE-1) as the study was closed out in the second quarter of 2025.

Current wording

Research and development expenses increased by $1.1 million, or 9%, for the three months ended September 30, 2025 compared to the same period in the prior year. The increase was primarily attributable to continued patient enrollment in our ICoN-1 clinical study for MNKD-101 and clinical production scale-up for MNKD-201. These increases were partially offset by the completion of our Afrezza clinical study (INHALE-3) and Phase 1 MNKD-201 studies in 2024, as well as lower costs for our Afrezza pediatric clinical study (INHALE-1) as the study was closed out in the second quarter of 2025.

Previous wording

Research and development expenses increased by $2.9 million, or 13%, for the six months ended June 30, 2025 compared to the same period in the prior year. The increase was primarily attributable to continued patient enrollment in our ICoN-1 clinical study for MNKD-101, clinical production scale-up for MNKD-201, and personnel costs primarily due to additional headcount as a result of the Pulmatrix transaction in the third quarter of 2024, which bolstered our research capabilities and capacity. These increases were partially offset by the completion of INHALE-3, the Phase 1 clinical study for MNKD-201, and toxicology studies in 2024, as well as lower costs for INHALE-1 as the study was closed out in the second quarter of 2025.

Current wording

Research and development expenses increased by $4.0 million, or 12%, for the nine months ended September 30, 2025 compared to the same period in the prior year. The increase was primarily attributable to continued patient enrollment in our ICoN-1 clinical study for MNKD-101, clinical production scale-up for MNKD-201, and personnel costs primarily due to additional headcount as a result of the Pulmatrix transaction in the third quarter of 2024, which bolstered our research capabilities and capacity. These increases were partially offset by the completion of INHALE-3, the Phase 1 clinical study for MNKD-201, and toxicology studies in 2024, as well as lower costs for INHALE-1 as the study was closed out in the second quarter of 2025.

Previous wording

Selling, general and administrative expenses increased by $7.5 million, or 31%, for the three months ended June 30, 2025 compared to the same period in the prior year. The increase was primarily driven by higher headcount and personnel-related costs including deploying a medical science liaison team and Afrezza promotional costs.

Current wording

Selling, general and administrative expenses increased by $5.2 million, or 22%, for the three months ended September 30, 2025 compared to the same period in the prior year. The increase was primarily driven by higher headcount and personnel-related costs including deploying a medical science liaison team and higher Afrezza promotional costs. Additionally, general and administrative expenses included $3.7 million of incremental costs associated with the acquisition of scPharma which was completed in October 2025. See Note 16– Subsequent Events.

Previous wording

Selling, general and administrative expenses increased by $10.2 million, or 22%, for the six months ended June 30, 2025 compared to the same period in the prior year. The increase was largely attributable to higher headcount and personnel-related expense as well as deploying a medical science liaison team and Afrezza promotional costs. These increases were partially offset by a $1.4 million charge recorded in the prior year period for estimated returns associated with sales of V-Go that pre-dated our acquisition of the product.

Current wording

Selling, general and administrative expenses increased by $15.4 million, or 22%, for the nine months ended September 30, 2025 compared to the same period in the prior year. The increase was largely attributable to higher headcount and personnel-related expense as well as deploying a medical science liaison team and Afrezza promotional costs. Additionally, general and administrative expenses included $3.7 million of incremental costs associated with the acquisition of scPharma, which was completed in October 2025. These increases were partially offset by a $1.4 million charge recorded in the prior year period for estimated returns associated with sales of V-Go that pre-dated our acquisition of the product.

Previous wording

Loss on foreign currency transaction was $5.4 million for the three months ended June 30, 2025 compared to a gain of $0.5 million for the same period in the prior year and a loss of $7.9 million for the six months ended June 30, 2025 compared to a gain of $1.9 million for the same period in the prior year. This was due to fluctuations in U.S. dollar to Euro exchange rates. Under the Insulin Supply Agreement with Amphastar, payment obligations for future purchases are denominated in Euros. We are required to record the foreign currency transaction impact of the U.S. dollar to Euro exchange rate associated with the recognized gain or loss on purchase commitments.

Current wording

Gain on foreign currency transaction was $0.1 million for the three months ended September 30, 2025 compared to a loss of $2.5 million for the same period in the prior year, and a loss of $7.8 million for the nine months ended September 30, 2025 compared to a loss of $0.5 million for the same period in the prior year. These non-cash changes were due to fluctuations in U.S. dollar to Euro exchange rates. Under the Insulin Supply Agreement with Amphastar, payment obligations for future purchases are denominated in Euros. We are required to record the foreign currency transaction impact of the U.S. dollar to Euro exchange rate associated with the recognized gain or loss on purchase commitments.

Previous wording

The following table provides a comparison of the other income (expense) categories for the three and six months ended June 30, 2025 and 2024 (dollars in thousands):

Current wording

The following table provides a comparison of the other income (expense) categories for the three and nine months ended September 30, 2025 and 2024 (dollars in thousands):

Previous wording

Interest income, net, consisting of interest and accretion on investments net of amortization, decreased by $1.3 million for the three months ended June 30, 2025 compared to the same period in the prior year and $2.8 million for the six months ended June 30, 2025 compared to the same period in the prior year. This was primarily due to a lower average balance on our securities portfolio and lower yields.

Current wording

Interest income, net, consisting of interest and accretion on investments net of amortization, decreased by $0.6 million for the three months ended September 30, 2025 compared to the same period in the prior year, and by $3.4 million for the nine months ended

Previous wording

Interest expense decreased by $5.8 million for the three months ended June 30, 2025 compared to the same period in the prior year and $3.7 million for the six months ended June 30, 2025 compared to the same period in the prior year. The decrease in interest was a result of the following principal debt reductions that occurred in 2024: (i) the exchange of an aggregate principal amount of approximately $193.7 million of our senior convertible notes due March 2026 in December 2024, (ii) $28.3 million full repayment to MidCap under the MidCap credit facility in April 2024, and (iii) the discharge and termination of $8.8 million of the outstanding principal balance under the Mann Group convertible note in April 2024.

Current wording

Interest expense decreased by $4.1 million for the nine months ended September 30, 2025 compared to the same period in the prior year as a result of the following principal debt reductions that occurred in 2024: (i) $28.3 million full repayment to MidCap under the MidCap credit facility in April 2024, (ii) the discharge and termination of $8.8 million of the outstanding principal balance under the Mann Group convertible note in April 2024 and (iii) the exchange of an aggregate principal amount of approximately $193.7 million of our senior convertible notes due March 2026 in December 2024.

Previous wording

Interest expense on liability for sale of future royalties decreased by $0.9 million and decreased by $1.6 million for the three and six months ended June 30, 2025 compared to the same periods in the prior year, respectively. Interest consists of imputed interest and the amortization of debt issuance costs on the liability recorded in connection with the sale of 1% of our Tyvaso DPI royalties in December 2023. See Note 14 –Commitments and Contingencies.

Current wording

Interest expense on liability for sale of future royalties decreased by $0.6 million and $2.2 million for the three and nine months ended September 30, 2025, respectively, compared to the same periods in the prior year. Interest consists of imputed interest and the amortization of debt issuance costs on the liability recorded in connection with the sale of 1% of our Tyvaso DPI royalties in December 2023. See Note 14 –Commitments and Contingencies.

Previous wording

Interest expense on financing liability was $2.4 million for the three months ended June 30, 2025 and 2024, and $4.8 million and $4.9 million for the six months ended June 30, 2025 and 2024, respectively. Interest expense on financing liability represented interest incurred on the sale lease-back transaction for our manufacturing facility in Danbury, Connecticut.

Current wording

Interest expense on financing liability was $2.5 million for each of the three months ended September 30, 2025 and 2024, and $7.3 million and $7.4 million for the nine months ended September 30, 2025 and 2024, respectively. Interest expense on financing liability represented interest incurred on the sale lease-back transaction for our manufacturing facility in Danbury, Connecticut.

Previous wording

Loss on available-for-sale securities for the three and six months ended June 30, 2024 was $1.6 million as a result of modification of the Thirona investment.

Current wording

Impairment of available-for-sale investment of $6.4 million for the three and nine months ended September 30, 2025 was a result of the write-off of the Thirona investment. Impairment of available-for-sale investment for the nine months ended September 30, 2024 was $1.6 million as a result of modification of the Thirona investment.

Previous wording

Loss on settlement of debt of $7.1 million for the three and six months ended June 30, 2024 was incurred in connection with the repayment of the MidCap credit facility and Mann Group convertible note in April 2024. See Note 8 –Borrowings.

Current wording

Loss on settlement of debt of $7.1 million for the nine months ended September 30, 2024 was incurred in connection with the repayment of the MidCap credit facility and Mann Group convertible note in April 2024. See Note 8 –Borrowings.

Previous wording

Represents the non-cash portion of the 1% royalty on net sales of Tyvaso DPI earned during the three and six months ended June 30, 2025 and 2024, which is remitted to the royalty purchaser and recognized as royalties from collaborations in our condensed consolidated statements of operations. Our royalties from collaborations during the three and six months ended June 30, 2025 totaled $31.2 million and $61.2 million, respectively, of which $3.1 million and $6.1 million, respectively were remitted to the royalty purchaser.

Current wording

Represents the non-cash portion of the 1% royalty on net sales of Tyvaso DPI earned during the three and nine months ended September 30, 2025 and 2024, which is remitted to the royalty purchaser and recognized as royalties from collaborations in our condensed consolidated statements of operations. Our royalties from collaborations during the three and nine months ended September 30, 2025 totaled $33.3 million and $94.6 million, respectively, of which $3.3 million and $9.5 million, respectively were remitted to the royalty purchaser.

Previous wording

As of June 30, 2025, we had $66.1 million in insulin purchase commitments and $36.3 million principal amount of outstanding senior convertible notes bearing interest at 2.50% and maturing on March 1, 2026, unless earlier converted, redeemed or repurchased by us. The senior convertible notes are convertible at an initial conversion price of approximately $5.21 per share of common stock. The conversion rate is subject to adjustment under certain circumstances in accordance with the terms of the Indenture. We may from time to time seek to retire or purchase our outstanding senior convertible notes, through cash purchases and/or exchanges for equity securities, in open market purchases, privately negotiated transactions or otherwise. Such repurchases or exchanges, if any, will depend on prevailing market conditions, our liquidity requirements, contractual restrictions, and other factors. The amounts involved in any such transactions, individually or in the aggregate, may be material.

Current wording

$36.3 million principal amount of outstanding senior convertible notes bearing interest at 2.50% and maturing on March 1, 2026, unless earlier converted, redeemed or repurchased by us. The senior convertible notes are convertible at an initial conversion price of approximately $5.21 per share of common stock. The conversion rate is subject to adjustment under certain circumstances in accordance with the terms of the Indenture. We may from time to time seek to retire or purchase our outstanding senior convertible notes, through cash purchases and/or exchanges for equity securities, in open market purchases, privately negotiated transactions or otherwise. Such repurchases or exchanges, if any, will depend on prevailing market conditions, our liquidity requirements, contractual restrictions, and other factors. The amounts involved in any such transactions, individually or in the aggregate, may be material.

Previous wording

During the six months ended June 30, 2025, we generated $2.6 million of cash from our operating activities. Cash used in operating activities consisted of net income of $13.8 million offset by non-cash adjustments of $30.6 million and a net decrease in cash flows from operating assets and liabilities of $41.8 million. Non-cash items primarily included stock-based compensation of $12.9 million, loss on foreign currency transactions of $7.9 million and interest on liability for sale of future royalties of $7.1 million. These charges were partially offset by the sold portion of royalty revenue of $6.1 million. The net decrease in cash flows from operating assets and liabilities was primarily due to an increase of $15.3 million in accounts receivable, decrease of $9.3 million in accrued expenses and other current liabilities and decrease of $7.1 million in deferred revenue.

Current wording

During the nine months ended September 30, 2025, we generated $26.2 million of cash from our operating activities. Cash used in operating activities consisted of net income of $21.8 million offset by non-cash adjustments of $47.0 million and a net decrease in cash flows from operating assets and liabilities of $42.6 million. Non-cash items primarily included stock-based compensation of $17.2 million, loss on foreign currency transactions of $7.8 million and interest on liability for sale of future royalties of $10.6 million. These charges were partially offset by the sold portion of royalty revenue of $9.5 million. The net decrease in cash flows from operating assets and liabilities was primarily due to a decrease of $12.4 million in prepaid expenses and other current assets and a decrease of $10.1 million in accrued expenses and other current liabilities.

Previous wording

During the six months ended June 30, 2024, we generated $10.5 million of cash from our operating activities. Cash used in operating activities consisted of net income of $8.6 million offset by non-cash adjustments of $26.5 million and a net decrease in cash flows from operating assets and liabilities of $24.6 million. Non-cash items primarily included stock-based compensation of $10.3 million and interest on liability for sale of future royalties of $8.6 million. These charges were partially offset by the sold portion of royalty revenue of $4.8 million. The net decrease in cash flows from operating assets and liabilities was primarily due to an increase of $8.9 million in accounts receivable, increase of $5.3 million in prepaid expenses and other current assets and a decrease of $5.3 million in deferred revenue.

Current wording

During the nine months ended September 30, 2024, we generated $19.9 million of cash from our operating activities. Cash used in operating activities consisted of net income of $20.2 million offset by non-cash adjustments of $32.0 million and a net decrease in cash flows from operating assets and liabilities of $32.3 million. Non-cash items primarily included stock-based compensation of $15.5 million, loss on foreign currency transactions of $0.5 million and interest on liability for sale of future royalties of $12.7 million. These charges were partially offset by the sold portion of royalty revenue of $7.5 million and a gain on bargain purchase of $5.3 million. The decrease in cash flows from operating assets and liabilities was primarily due to a decrease of $7.2 million in deferred revenue, decrease of $6.4 million in prepaid expenses and other current assets and a decrease of $4.8 million in accrued expenses and other current liabilities.

Previous wording

Cash provided by investing activities of $12.2 million for the six months ended June 30, 2025 was primarily due to the maturity of $101.8 million of debt securities, partially offset by the purchase of $88.1 million of debt securities.

Current wording

Cash used in investing activities of $12.8 million for the nine months ended September 30, 2025 was primarily due to the $10.0 million issuance of a note receivable and the purchase of $144.1 million of debt securities, partially offset by the maturity of $143.8 million of debt securities.

Previous wording

Cash used in investing activities of $103.6 million for the six months ended June 30, 2024 was primarily due to the purchase of $187.4 million of debt securities and $5.4 million of property and equipment, partially offset by the maturity of $88.8 million of debt securities.

Current wording

Cash used in investing activities of $144.9 million for the nine months ended September 30, 2024 was primarily due to the purchase of $273.8 million of debt securities and $6.8 million of property and equipment, partially offset by the maturity of $135.3 million of debt securities.

Previous wording

Cash used in financing activities of $4.1 million for the six months ended June 30, 2025 was primarily due to $4.4 million of payments to taxing authorities from equity withheld upon vesting of RSUs and stock options partially offset by $1.3 million in proceeds from our market price stock purchase plan and employee stock purchase plan.

Current wording

Cash provided by financing activities of $67.7 million for the nine months ended September 30, 2025 was primarily due to proceeds from a term loan of $75.0 million under the Blackstone Credit Facility, partially offset by $5.1 million of payments to taxing authorities from equity withheld upon vesting of RSUs and stock options and loan issuance costs of $2.3 million.

Previous wording

Cash used in financing activities of $48.0 million for the six months ended June 30, 2024 was primarily due to principal and early extinguishment payments on the MidCap credit facility of $36.6 million and Mann Group convertible note of $8.9 million, and $4.7 million of payments to taxing authorities from equity withheld upon vesting of RSUs and stock options, partially offset by $2.3 million in proceeds from the market price stock purchase plan and employee stock purchase plan.

Current wording

Cash used in financing activities of $50.4 million for the nine months ended September 30, 2024 was primarily due to principal and early extinguishment payments on the MidCap credit facility of $36.6 million and Mann Group convertible note of $8.9 million, and $6.2 million of payments to taxing authorities from equity withheld upon vesting of RSUs and stock options, partially offset by $2.3 million in proceeds from the MPSPP and ESPP.

Previous wording

We believe we will be able to meet our near-term liquidity needs based on our cash, cash equivalents and investments on hand, sales of Afrezza and V-Go, and royalties and manufacturing revenue from the production and sale of Tyvaso DPI as well as through debt or equity financing, if necessary, for our long-term liquidity needs. We expect to continue to incur expenditures for the foreseeable future in support of our manufacturing operations, sales and marketing costs for our products and development costs for other product candidates in our pipeline. As of June 30, 2025, we had capital resources comprised of cash, cash equivalents, short-term investments and long-term investments totaling $201.2 million, and total principal amount of outstanding borrowings of $36.3 million.

Current wording

We believe we will be able to meet our near-term liquidity needs based on our cash, cash equivalents and investments on hand, sales of Afrezza, V-Go and Furoscix, royalties and manufacturing revenue from the production and sale of Tyvaso DPI and borrowings under the Blackstone Credit Facility, as well as through debt or equity financing, if necessary, for our long-term liquidity needs. We expect to continue to incur expenditures for the foreseeable future in support of our manufacturing operations, sales and marketing costs for our products and development costs for other product candidates in our pipeline. As of September 30, 2025, we had capital resources comprised of cash, cash equivalents, short-term investments and long-term investments totaling $286.3 million, and total principal amount of outstanding borrowings of $111.3 million, which amounts do not take into account our completion of the scPharma acquisition in October 2025 and the scPharma Debt Extinguishment, and our additional $250.0 million term loan borrowing in October 2025 under the Blackstone Credit Facility in connection with such acquisition. See Note 16 –Subsequent Events.
Rearranged current paragraphs (4)

Current report — wording carried from elsewhere

Afrezza and V-Go, from royalties and manufacturing revenue from UT, from proceeds of the sale-leaseback of our manufacturing facility in Danbury, CT and from the sale of a portion of future royalties that we receive from UT.

Current report — wording carried from elsewhere

Royalty revenue from UT increased by $6.2 million, or 23%, for the three months ended September 30, 2025 and $19.2 million, or 26%, for the nine months ended September 30, 2025 due to UT's increase in net revenue from sales of Tyvaso DPI.

Current report — wording carried from elsewhere

September 30, 2025 compared to the same period in the prior year. These decreases were primarily due to a lower average balance on our securities portfolio and lower yields.

Current report — wording carried from elsewhere

Interest expense decreased by $0.4 million for the three months ended September 30, 2025 compared to the same period in the prior year due to a principal debt reduction from the exchange of an aggregate principal amount of approximately $193.7 million of our senior convertible notes due March 2026 in December 2024.
Rearranged previous paragraphs (2)

Previous report — wording carried elsewhere

The first product to come out of our orphan lung disease pipeline, Tyvaso DPI (treprostinil) inhalation powder, received FDA approval in May 2022 for the treatment of PAH and PH-ILD. Our development and marketing partner, United Therapeutics, began commercializing Tyvaso DPI in June 2022 and is obligated to pay us a royalty on net sales of the product. We also receive a margin on supplies of Tyvaso DPI that we manufacture for UT.

Previous report — wording carried elsewhere

Cost of revenue – collaborations and services increased by $1.2 million, or 8%, for the three months ended June 30, 2025 compared to the same period in the prior year. The increase was primarily attributable to an increase in production related write-offs for the period.